Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format, 68334-68340 [2019-27047]
Download as PDF
<![CDATA[
68334
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
under the Paperwork Reduction Act of
1995 is not required.
IX. Federalism
We have analyzed this final rule in
accordance with the principles set forth
in E.O. 13132. We have determined that
the rule does not contain policies that
have substantial direct effects on the
States, on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the E.O. and,
consequently, a federalism summary
impact statement is not required.
X. Consultation and Coordination With
Indian Tribal Governments
We have analyzed this rule in
accordance with the principles set forth
in E.O. 13175. We have determined that
the rule does not contain policies that
have substantial direct effects on one or
more Indian Tribes, on the relationship
between the Federal Government and
Indian Tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian Tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the E.O.
and, consequently, a tribal summary
impact statement is not required.
lotter on DSKBCFDHB2PROD with RULES
XI. Reference
The following reference is on display
in the Dockets Management Staff (see
ADDRESSES), and is available for viewing
by interested persons between 9 a.m.
and 4 p.m. Monday through Friday; it is
also available electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. FDA Final Regulatory Impact
Analysis, ‘‘Regulation Requiring an
Approved New Drug Application for
Drugs Sterilized by Irradiation,’’
available at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
List of Subjects in 21 CFR Part 310
Administrative practice and
procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act and under authority
delegated to the Commissioner of Food
and Drugs, 21 CFR part 310 is amended
as follows:
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
DATES:
PART 310—NEW DRUGS
This rule is effective January 15,
2020.
1. The authority citation for part 310
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360b–360f, 360j, 360hh–360ss,
361(a), 371, 374, 375, 379e, 379k–1; 42 U.S.C.
216, 241, 242(a), 262.
2. In § 310.502, revise paragraph (a)
introductory text and remove and
reserve paragraph (a)(11) to read as
follows:
■
§ 310.502 Certain drugs accorded new
drug status through rulemaking
procedures.
(a) The drugs listed in this paragraph
(a) have been determined by rulemaking
procedures to be new drugs within the
meaning of section 201(p) of the Federal
Food, Drug, and Cosmetic Act. An
approved new drug application under
section 505 of the Federal Food, Drug,
and Cosmetic Act and part 314 of this
chapter is required for marketing the
following drugs:
*
*
*
*
*
Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019–27046 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 807, 812, and 814
[Docket No. FDA–2018–N–0628]
RIN 0910–AH48
Medical Device Submissions:
Amending Premarket Regulations That
Require Multiple Copies and Specify
Paper Copies To Be Required in
Electronic Format
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, Agency, or we) is
issuing a final rule amending
requirements for medical device
premarket submissions to remove paper
and multiple copies and replace them
with requirements for a single
submission in electronic format. This
action would reduce the number of
copies in electronic format required,
thus improving and making more
efficient the FDA’s premarket
submission program for medical
devices.
SUMMARY:
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number found in brackets in the
heading of this final rule into the
‘‘Search’’ box and follow the prompts,
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Diane Garcia, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G609, Silver Spring,
MD 20993, 301–796–6559, email:
Diane.Garcia@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the
Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used
Acronyms in This Document
III. Background
A. Need for the Regulation/History of This
Rulemaking
B. Summary of Comments to the Proposed
Rule
C. General Overview of Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA
Response
A. Introduction
B. Description of General Comments and
FDA Response
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with
Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
FDA is issuing this final rule to
amend regulations on medical device
premarket submissions to remove
requirements for paper and multiple
copies and replace them with
requirements for a single submission in
electronic format to improve the FDA’s
medical device premarket submission
program and create a more efficient
submission program. Because a medical
device premarket submission in
electronic format is easily reproducible,
the requirement for multiple copies,
whether in electronic format or paper
form, is no longer necessary. FDA
believes it is beneficial to the public to
limit any burden and expense to
E:\FR\FM\16DER1.SGM
16DER1
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
submitters caused by requiring
additional copies.
regulations for the efficient enforcement
of the FD&C Act.
B. Summary of the Major Provisions of
the Final Rule
D. Costs and Benefits
Under this final rule, FDA is
amending its regulations on medical
device submissions to remove
requirements for paper and multiple
copies and replace them with
requirements for a single submission in
electronic format. This requirement for
a single submission in electronic format
applies to all submission types
enumerated in section 745A(b)(1) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379k–1); under
this final rule, FDA is only amending
those regulations that specifically
mention paper and/or multiple copies of
regulatory submissions and are not
consistent with this final rule.
Therefore, this final rule will amend
regulations for the following submission
types: Premarket Notification (510(k))
submissions (21 CFR 807.90);
Confidentiality of Information
Certifications (21 CFR 807.95);
Investigational Device Exemption (IDE)
applications (21 CFR 812.20); Premarket
Approval Applications (PMAs) (21 CFR
814.20); PMA supplements (21 CFR
814.39); and Humanitarian Device
Exemption (HDE) Applications (21 CFR
814.104). These regulations cover both
Center for Devices and Radiological
Health (CDRH) and Center for Biologics
Evaluation and Research (CBER)
regulated devices. Submissions in
electronic format include eCopies,
submissions created and submitted on
CD, DVD, or flash drive and mailed to
FDA, and eSubmissions, submission
package produced by an electronic
submission template.
This final rule will also amend
sections of the regulations that identify
FDA’s mailing address for submissions
and replace those addresses with a
website address for CDRH and CBER
that provides the current mailing
addresses.
lotter on DSKBCFDHB2PROD with RULES
C. Legal Authority
FDA is issuing this final rule from the
same authority under which FDA
initially issued these regulations: 21
U.S.C. 321, 331, 351, 352, 353, 355, 360,
360h–360j, 360c–360j, 360bbb–8b, 371,
372, 373, 374, 375, 379, 379e, 381, 382,
393; 42 U.S.C. 216, 241, 262, 263b–
263n, 264, 271. In addition, section
745A of the FD&C Act provides FDA
authority with respect to electronic
format for submissions and any appeals,
and section 701(a) of the FD&C Act (21
U.S.C. 371(a)) grants FDA general
rulemaking authority to issue
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
The final rule amends device
regulations describing the number of
copies firms must submit with a
premarket presubmission or submission.
The final rule also amends all device
regulations containing a reference to the
specific form of a submission to require
a submission in electronic format. The
final rule will produce cost savings for
firms without imposing any additional
regulatory burdens for submissions or
affecting the Agency’s ability to review
submissions. Firms will incur minimal
administrative costs to read and
understand the rule. We expect the
economic impact of this regulation to be
a total net costs savings yielding
positive net benefits.
We estimate that the final rule will
result in annualized benefits of $1.76
million at a 3 percent discount rate and
$1.76 million at a 7 percent discount
rate, over 10 years. We also estimate that
the final rule will result in annualized
costs of $0.75 million at a 3 percent
discount rate and $0.87 million at a 7
percent discount rate, over 10 years.
II—TABLE OF ABBREVIATIONS/COMMONLY USED ACRONYMS IN THIS
DOCUMENT
Term,
abbreviation,
or acronym
510(k) .............
Agency ...........
CFR ................
eCopy .............
eSubmissions
EO ..................
FD&C Act .......
FDA ................
FDARA ...........
FDASIA ..........
HDE ...............
IDE .................
PMA ...............
PO 00000
Frm 00011
What it means
Premarket Notification.
Food and Drug Administration.
Code of Federal Regulations.
Submissions created and
submitted on CD, DVD, or
flash drive and mailed to
FDA.
Submission package produced by an electronic
submission template.
Executive Order.
Federal Food, Drug, and
Cosmetic Act, 21 U.S.C.
301 et seq.
Food and Drug Administration.
FDA Reauthorization Act of
2017 (Pub. L. 115–52).
Food and Drug Administration Safety and Innovation
Act (Pub. L. 112–144).
Humanitarian Device Exemption.
Investigational Device Exemption
Premarket Approval Application.
Fmt 4700
Sfmt 4700
68335
II. Background
A. Need for the Regulation/History of
the Rulemaking
On February 24, 2017, E.O. 13777,
‘‘Enforcing the Regulatory Reform
Agenda’’ was issued. One of the
provisions in the E.O. requires Agencies
to evaluate existing regulations and
make recommendations to the Agency
head regarding their repeal,
replacement, or modification, consistent
with applicable law. As part of this
initiative, FDA is updating regulations
as specified in this final rule.
FDA’s current medical device
regulations that require multiple copies
and paper submissions predate the
authority provided to FDA in the FD&C
Act to require submissions in electronic
format (see 21 CFR parts 807, 812, and
814 and section 745A of the FD&C Act).
The FD&C Act was amended by the
Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L.
112–144) (see section 745A(b) of the
FD&C Act and section 1136 of FDASIA).
The amendments in FDASIA provided
that after FDA issued guidance on the
submission of electronic copies
(eCopies), the submission of eCopies
would be required for presubmissions
and submissions and any supplements
to these presubmissions and
submissions for medical devices. (For
sections requiring submission, see
sections 510(k), 513(f)(2)(A), 515(c), (d)
and (f), 520(g) and (m), and 564 of the
FD&C Act (21 U.S.C. 360(k),
360c(f)(2)(A), 360e(c), (d) and (f), 360j(g)
and (m), and 360bbb–3 or section 351 of
the Public Health Service Act (42 U.S.C.
262).) Congress granted explicit
statutory authorization to FDA to
implement eCopy requirements by
providing through guidance the
standards and criteria for waivers and
exemptions (section 745(b)(1) and (2) of
the FD&C Act).
On January 2, 2013, FDA published
the guidance entitled ‘‘eCopy Program
for Medical Device Submissions’’
(eCopy guidance). The issuance of the
eCopy guidance marked the beginning
of the eCopy program. The 2013
guidance was superseded by an updated
guidance of the same title issued on
December 3, 2015. The eCopy guidance
recommends that one paper copy
should be submitted, and that any
additional copies required under the
regulations be submitted as eCopies.
While the eCopy guidance did not
change the overall number of copies
required for any submission, the
guidance states that eCopies should be
provided in lieu of some of the paper
copies. The guidance also outlines other
requirements for eCopies. The eCopy
E:\FR\FM\16DER1.SGM
16DER1
68336
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
lotter on DSKBCFDHB2PROD with RULES
guidance provides instructions for the
processing and technical standards for
eCopies based on FDA’s experience
with the program (Ref. 1).
In 2017, the FD&C Act was amended
by the FDA Reauthorization Act of 2017
(FDARA) (Pub. L. 115–52) (see section
745A(b)(3) of the FD&C Act and section
207 of FDARA). The amended
provisions in the FD&C Act require
presubmissions and submissions (the
same types of submissions as required
eCopies), any supplements to such
presubmissions or submissions for
devices, and any appeals of action taken
with respect to such presubmissions or
submissions, including devices under
the Public Health Service Act, to be
submitted solely in electronic format as
specified by FDA in guidance (section
745A(b)(3) of the FD&C Act).
FDA is amending current medical
device regulations that require multiple
copies and paper submissions to
improve the efficiency of the review
process by allowing immediate
availability of an electronic version for
review, rather than relying solely on the
paper version. Because a submission in
electronic format is easily reproducible,
the requirement for multiple copies
(whether in electronic format or paper
form) is no longer necessary.
Furthermore, FDA believes it is
beneficial to the public to limit any
burdens and expenses to submitters
caused by requiring additional copies.
In the Federal Register of September
13, 2018 (83 FR 46444), FDA issued a
proposed rule entitled ‘‘Medical Device
Submissions: Amending Premarket
Regulations That Require Multiple
Copies and Specify Paper Copies To Be
Allowed in Electronic Format’’ and
requested public comments by
December 12, 2018.
FDA believes this rule will result in
meaningful burden reduction while
allowing the Agency to achieve our
public health mission and fulfill
statutory obligations.
B. Summary of Comments to the
Proposed Rule
In response to the proposed rule, FDA
received 14 comments—from industry
organizations, individuals, and
anonymous. The comments on the
proposed rule were all generally
supportive of the proposed amendments
regarding submissions in electronic
format. Commenters expressed that
premarket submissions in electronic
format will make the process more
efficient, faster, lower the costs, and
promote innovation as well as speed up
accessibility for patient care.
Commenters also noted that the
submissions in electronic format will
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
reduce paper, errors and allow storage
and easy access to submissions. One of
the commenters suggested including
additional regulations for submissions
in electronic format and recommended
corresponding changes to the proposed
amendments.
C. General Overview of the Final Rule
FDA is issuing this final rule to
amend regulations for medical device
premarket submissions to remove the
requirements for multiple copies of
submissions and to instead require a
single submission in electronic format.
The revised submissions include
premarket notification submissions
(510(k) submissions) (§ 807.90);
confidentiality of information
certification (§ 807.95); investigational
device exemption applications
(§ 812.20); PMAs (§ 814.20), including
PMA supplements (§ 814.39); and
humanitarian device exemption
applications (§ 814.104). This final rule
also affects submissions for CBER
regulated devices.
This final rule will also amend the
regulations that identify FDA’s mailing
addresses for submissions by replacing
those addresses with website addresses
for CDRH and CBER that provide the
current mailing addresses.
The submission of an eCopy is
separate and distinct from FDA’s
electronic submission programs
(eSubmitter), which include the CDRH’s
510(k) eSubmissions Pilot Program (79
FR 24732, May 1, 2014). Nevertheless,
FDA considers both eCopies,
submissions created and submitted on a
CD, DVD, or flash drive and mailed to
FDA, and eSubmissions, submission
package produced by an electronic
submission template, to be submissions
in electronic format. While eCopy
provides for submissions to be in
electronic format, the eCopy
submissions must still be mailed to
FDA. By contrast, eSubmitter allows for
electronic submissions to be transmitted
over the internet. FDA has been moving
toward transforming all regulatory
submissions from mailed copies to
electronic means via the internet. Since
January 1999, FDA has accepted
voluntary electronic submissions
through eSubmitter. FDA presently
utilizes the Electronic Submission
Gateway for the receipt and processing
of many types of electronic regulatory
submissions (Ref. 2).
IV. Legal Authority
FDA is issuing this final rule from the
same authority under which FDA
initially issued these regulations: 21
U.S.C. 321, 331, 351, 352, 353, 355, 360,
360h–360j, 360c–360j, 360bbb–8b, 371,
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
372, 373, 374, 375, 379, 379e, 381, 382,
393; 42 U.S.C. 216, 241, 262, 263b–
263n, 264, 271. In addition, section
745A of the FD&C Act provides FDA
authority with respect to electronic
format for submissions and any appeals,
and section 701(a) of the FD&C Act
grants FDA general rulemaking
authority to issue regulations for the
efficient enforcement of the FD&C Act.
V. Comments on the Proposed Rule and
FDA Response
A. Introduction
In response to the proposed rule
announcing FDA’s intent to amend
requirements for medical device
premarket submissions to remove paper
and multiple copies and replace them
with requirements for a single
submission in electronic format, FDA
received 14 comments—from industry
organizations, individuals, and
anonymous.
We describe and respond to the
comments in section V.B. We have
numbered each comment to help
distinguish between different
comments. We have grouped similar
comments under the same number for
purposes of our responses. The number
assigned to each comment or comment
topic is purely for organizational
purposes and does not signify the
comment’s value or importance or the
order in which comments were
received.
B. Description of Comments and FDA
Response
Several commenters made general
remarks supporting the proposed rule
without focusing on a particular
proposed provision. In the following
paragraphs, we discuss and respond to
such general comments as well as more
specific comments.
(Comment 1) Several commenters
were supportive of the implementation
of the proposed amendments to
regulations on medical device
submissions to remove requirements for
paper and multiple copies and replace
them with requirements for a single
submission in electronic format. The
commenters suggested that single copy
submissions in electronic format will be
easier, improve efficiency of the review
process, reduce paper, costs, errors, and
support innovation. The commenters
also suggested that submissions in
electronic format will provide easy
storage and access to records and reduce
the time for creating the submissions.
Most of the commenters did not suggest
any further edits to the proposed rule.
A commenter suggested assigning IDs or
reference numbers to each product to
E:\FR\FM\16DER1.SGM
16DER1
lotter on DSKBCFDHB2PROD with RULES
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
advance post market surveillance of
medical devices.
(Response 1) FDA agrees with the
commenters that submission in
electronic format will improve the
efficiency with lower costs and easier
storage and access to records. Regarding
the comment related to the ID/reference
numbers, FDA did not modify the final
rule based on this comment as it is
outside the scope of the requirement for
a single submission in electronic format.
Accordingly, in response to this
comment, FDA did not make any
changes in the final rule.
(Comment 2) A commenter supported
the implementation of the rule but also
suggested that electronic submissions be
made via the internet, in an Extensible
Markup Language (XML) format. The
commenter suggested that FDA should
be developing specifications for
industry submission authoring software
that would integrate directly into FDA’s
review platform; the commenter
explained that this type of submission
authoring software could create
elements of structured data within a
submission.
(Response 2) In response, FDA
acknowledges the advantages of
electronic submissions. FDA notes that
the rule is written broadly enough to
permit electronic submissions and allow
for structured data when such platforms
are available. Accordingly, we have
made no change in the final rule.
(Comment 3) A commenter suggested
applying a logical and least burdensome
approach in all FDA guidances,
regulatory decisions, and administrative
processes. The commenter further
indicated that they supported removing
paper and multiple copies and replacing
them with a single submission in
electronic format.
(Response 3) FDA acknowledges this
comment and agrees that the least
burdensome principles should be
considered in all FDA guidances,
regulatory decisions and administrative
processes (Ref. 3). FDA believes this
final rule limits any burdens and
expenses to submitters caused by
requiring multiple copies of a
submission. Accordingly, in response to
this comment, FDA did not make any
changes in the final rule.
(Comment 4) A commenter
acknowledged the benefits of the rule
and supported implementation with a
recommendation to amend the rule and
include additional regulations within
the scope and description of the rule.
Specifically, the commenter proposed
revising FDA’s regulation for devices to
remove the requirement for multiple
copies of submissions and to instead
require one electronic version for those
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
regulations noted in the proposed rule
in addition to the following: Content
and format of a 510(k) summary
(§ 807.92); content and format of a
510(k) statement (§ 807.93); format of a
class III certification (§ 807.94);
supplemental applications (§ 812.35);
reports (§ 812.150); reports (§ 814.84);
PMA amendments and submitted PMAs
(§ 814.37); and post approval
requirements and reports (§ 814.126).
(Response 4) FDA agrees with the
commenter that this rule should apply
to all premarket regulatory submissions
that are specified in section 745A(b) of
the FD&C Act. The requirement for a
single submission in electronic format
applies to all submission types that fall
within the provisions listed in section
745A(b) of the FD&C Act; under this
final rule, FDA is only amending those
regulations that specifically mention
paper and/or multiple copies of such
regulatory submissions and are not
consistent with this final rule. Any
regulations that are currently silent on
the method for submitting such
regulatory submissions to the FDA will
not be modified as they remain
consistent with the final rule.
Accordingly, in response to this
comment, FDA did not make any
changes in the final rule.
VI. Effective Date
The final rule will become effective
30 days after the date of publication in
the Federal Register.
VII. Economic Analysis of Impacts
We have examined the impacts of the
final rule under E.O. 12866, E.O. 13563,
E.O. 13771, the Regulatory Flexibility
Act (5 U.S.C. 601–612), and the
Unfunded Mandates Reform Act of 1995
(Pub. L. 104–4). E.O.s 12866 and 13563
direct us to assess all costs and benefits
of available regulatory alternatives and,
when regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety, and other advantages;
distributive impacts; and equity). E.O.
13771 requires that the costs associated
with significant new regulations ‘‘shall,
to the extent permitted by law, be offset
by the elimination of existing costs
associated with at least two prior
regulations.’’ We believe that this final
rule is not a significant regulatory action
as defined by E.O. 12866.
The Regulatory Flexibility Act
requires us to analyze regulatory options
that would minimize any significant
impact of a rule on small entities.
Because the final rule amends the
existing premarket regulations requiring
multiple copies and paper submissions
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
68337
to instead require submissions in
electronic format without imposing any
new requirements, we certify that the
final rule will not have a significant
economic impact on a substantial
number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before proposing
‘‘any rule that includes any Federal
mandate that may result in the
expenditure by State, local, and tribal
governments, in the aggregate, or by the
private sector, of $100,000,000 or more
(adjusted annually for inflation) in any
one year.’’ The current threshold after
adjustment for inflation is $154 million,
using the most current (2018) Implicit
Price Deflator for the Gross Domestic
Product. This final rule will not result
in an expenditure in any year that meets
or exceeds this amount.
This final rule will amend the device
regulations describing the number of
copies firms must submit with a
premarket presubmission or submission.
The final rule will also amend all device
regulations containing a reference to the
specific form of a submission media
(i.e., paper copies) to require a
submission in electronic format. The
final rule will produce cost-savings for
firms without imposing any additional
regulatory burdens for submissions or
affecting the Agency’s ability to review
submissions. Firms will incur minimal
administrative costs to read and
understand the rule. We expect the
economic impact of this regulation to be
a total net costs savings yielding
positive net benefits.
We have developed a comprehensive
final Economic Analysis of Impacts that
assesses the impacts of the final rule.
The full analysis of economic impacts is
available in the docket for this final rule
(Ref. 4) and at https://www.fda.gov/
about-fda/reports/economic-impactanalyses-fda-regulations.
Summary of Costs and Benefits
Table 1 summarizes the benefits,
costs, and distributional effects of the
final rule. We estimate that the final rule
will result in annualized net benefits of
$1.76 million with a 3 percent discount
rate and $1.76 million with a 7 percent
discount rate, over 10 years. We also
estimate that the final rule will result in
annualized costs of $0.75 million at a 3
percent discount rate and $0.87 million
at a 7 percent discount rate, over 10
years.
E:\FR\FM\16DER1.SGM
16DER1
68338
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF FINAL RULE
Units
Category
Benefits:
Annualized Monetized $millions/year ..................
Annualized Quantified ..........................................
Primary
estimate
Low
estimate
High
estimate
$1.76
1.76
..................
..................
$0.63
0.63
..................
..................
$3.73
3.73
..................
..................
2017
2017
..................
..................
7
3
7
3
10
10
..................
..................
0.87
0.75
..................
..................
0.87
0.75
..................
..................
0.87
0.75
..................
..................
2017
2017
..................
..................
7
3
7
3
10
10
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
7
3
..................
..................
7
3
..................
..................
Year
dollars
Discount
rate
(%)
Period
covered
(years)
Notes
Benefits are cost savings.
Benefits are cost savings.
Qualitative ............................................................
Costs:
Annualized Monetized $millions/year ..................
Annualized Quantified ..........................................
Qualitative ............................................................
Transfers:
Federal Annualized Monetized $millions/year .....
From:
Other Annualized Monetized $millions/year ........
To:
..................
..................
..................
..................
..................
..................
From:
In line with E.O. 13771, in Table 2 we
present annualized values of costs and
cost savings over an infinite time
horizon. With a 7 percent discount rate,
..................
..................
To:
the estimated annualized net costsavings equal $1.31 million in 2016
dollars over an infinite horizon. Based
on these cost savings, this final rule, is
considered a deregulatory action under
E.O. 13771.
TABLE 2—SUMMARY OF THE EXECUTIVE ORDER 13771 IMPACTS OF THE FINAL RULE OVER AN INFINITE TIME HORIZON
[2016 $ millions]
Primary
estimate
(7%)
Present Value of Costs ............................................................................................................................................
Present Value of Cost Savings ...............................................................................................................................
Present Value of Net Costs .....................................................................................................................................
Annualized Costs .....................................................................................................................................................
Annualized Cost Savings .........................................................................................................................................
Annualized Net Costs ..............................................................................................................................................
$6.43
26.45
(20.01)
0.42
1.73
(1.31)
Primary
estimate
(3%)
$6.43
59.40
(52.97)
0.19
1.73
(1.54)
Note: Values in parentheses denote net negative costs (i.e., cost-savings).
VIII. Analysis of Environmental Impact
We have determined under 21 CFR
25.30(h) and 25.34(a) that this action is
of a type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
lotter on DSKBCFDHB2PROD with RULES
IX. Paperwork Reduction Act of 1995
FDA concludes that this final rule
contains no collection of information
subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995.
Rather, the final rule removes
requirements to submit multiple paper
copies of certain medical device
VerDate Sep<11>2014
17:29 Dec 13, 2019
Jkt 250001
presubmissions and submissions and
replaces them with one copy in an
electronic format.
consequently, a federalism summary
impact statement is not required.
X. Federalism
XI. Consultation and Coordination With
Indian Tribal Governments
We have analyzed this final rule in
accordance with the principles set forth
in E.O. 13132. FDA has determined that
the rule does not contain policies that
have substantial direct effects on the
States, on the relationship between the
National Government and the States, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
conclude that the rule does not contain
policies that have federalism
implications as defined in the E.O. and,
We have analyzed this final rule in
accordance with the principles set forth
in E.O. 13175. We have determined that
the rule does not contain policies that
would have a substantial direct effect on
one or more Indian Tribes, on the
relationship between the Federal
Government and Indian Tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian Tribes.
Accordingly, we conclude that the rule
does not contain policies that have
tribal implications as defined in the
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
E:\FR\FM\16DER1.SGM
16DER1
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
Executive Order and, consequently, a
tribal summary impact statement is not
required.
XII. References
lotter on DSKBCFDHB2PROD with RULES
The following references are on
display at Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. FDA has verified
the website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
PART 807—ESTABLISHMENT
REGISTRATION AND DEVICE LISTING
FOR MANUFACTURERS AND INITIAL
IMPORTERS OF DEVICES
1. The authority citation for part 807
is revised to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
360, 360c, 360e, 360i, 360j, 360bbb–8b, 371,
374, 379k–1, 381, 393; 42 U.S.C. 264, 271.
2. Amend § 807.90 by revising
paragraph (a), removing and reserving
paragraph (b), and revising paragraph (c)
to read as follows:
■
§ 807.90 Format of a premarket notification
submission.
*
*
*
*
1. ‘‘eCopy Program for Medical Device
(a)(1) For devices regulated by the
Submissions; Guidance for Industry and
Center for Devices and Radiological
Food and Drug Administration Staff’’
Health, be addressed to the current
available at: https://www.fda.gov/regulatoryaddress displayed on the website
information/search-fda-guidance-documents/ https://www.fda.gov/
ecopy-program-medical-device-submissions.
cdrhsubmissionaddress.
2. Electronic Submission Gateway
(2) For devices regulated by the
procedure for electronic regulatory
Center for Biologics Evaluation and
submission is available at: https://
Research, be addressed to the current
www.fda.gov/industry/electronicaddress displayed on the website
submissions-gateway/about-esg.
https://www.fda.gov/AboutFDA/
3. ‘‘The Least Burdensome Provisions:
CentersOffices/
Concept and Principles; Guidance for
OfficeofMedicalProductsandTobacco/
Industry and Food and Drug Administration
CBER/ucm385240.htm; or for devices
Staff’’ available at: https://www.fda.gov/
regulated by the Center for Drug
regulatory-information/search-fda-guidanceEvaluation and Research, be addressed
documents/least-burdensome-provisionsto the Central Document Room, Center
concept-and-principles.
for Drug Evaluation and Research, Food
4. Economic impacts analysis for this final
and Drug Administration, 5901–B
rule available at: https://www.fda.gov/aboutAmmendale Rd., Beltsville, MD 20705–
fda/economic-impact-analyses-fda1266. Information about devices
regulations/medical-device-submissionsregulated by the Center for Biologics
amending-premarket-regulations-requireEvaluation and Research is available at
multiple-copies-and-specify-paper.
https://www.fda.gov/
BiologicsBloodVaccines/
List of Subjects
BloodBloodProducts/
21 CFR Part 807
ApprovedProducts/default.htm.
(3) All inquiries regarding a premarket
Confidential business information,
notification submission should be sent
Imports, Medical devices, Reporting and to the address in this section or one of
recordkeeping requirements.
the current addresses displayed on the
Food and Drug Administration’s
21 CFR Part 812
website.
Health records, Medical devices,
*
*
*
*
*
Medical research, Reporting and
(c) Be submitted as a single version in
recordkeeping requirements.
electronic format.
*
*
*
*
*
21 CFR Part 814
■ 3. Amend § 807.95 by revising
Administrative practice and
paragraph (b)(1) introductory text to
procedure, Confidential business
read as follows:
information, Medical devices, Medical
§ 807.95 Confidentiality of information.
research, Reporting and recordkeeping
requirements.
*
*
*
*
*
(b) * * *
Therefore, under the Federal Food,
(1) The person submitting the
Drug, and Cosmetic Act and under the
premarket
notification submission
authority delegated to the Commissioner
requests in the submission that the Food
of Food and Drugs, 21 CFR parts 807,
and Drug Administration hold as
812, and 814 are amended as follows:
confidential commercial information the
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
*
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
68339
intent to market the device and submits
a certification to the Commissioner:
*
*
*
*
*
PART 812—INVESTIGATIONAL
DEVICE EXEMPTIONS
4. The authority citation for part 812
is revised to read as follows:
■
Authority: 21 U.S.C. 331, 351, 352, 353,
355, 360, 360c–360f, 360h–360j, 360bbb–8b,
371, 372, 374, 379e, 379k–1, 381, 382, 383;
42 U.S.C. 216, 241, 262, 263b–263n.
5. Amend § 812.19 by revising
paragraphs (a)(1) and (2) to read as
follows:
■
§ 812.19 Addresses for IDE
correspondence.
(a) * * *
(1) For devices regulated by the
Center for Devices and Radiological
Health, send it to the current address
displayed on the website https://
www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the
Center for Biologics Evaluation and
Research, send it to the current address
displayed on the website https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CBER/ucm385240.htm.
*
*
*
*
*
■ 6. Amend § 812.20 by revising
paragraph (a)(3) to read as follows:
§ 812.20
Application.
(a) * * *
(3) A sponsor shall submit a signed
‘‘Application for an Investigational
Device Exemption’’ (IDE application),
together with accompanying materials
in electronic format, to one of the
addresses in § 812.19, and if eCopy by
registered mail or by hand. Subsequent
correspondence concerning an
application or a supplemental
application shall be submitted in
electronic format and if eCopy by
registered mail or by hand.
*
*
*
*
*
PART 814—PREMARKET APPROVAL
OF MEDICAL DEVICES
7. The authority citation for part 814
is revised to read as follows:
■
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 360bbb–8b, 371, 372, 373, 374,
375, 379, 379e, 379k–1, 381.
8. Amend § 814.20 by:
a. Revising paragraph (b) introductory
text and paragraph (b)(2);
■ b. Removing the phrase ‘‘of the act’’
and adding in its place ‘‘of the Federal
Food, Drug, and Cosmetic Act’’ in
paragraphs (b)(5) introductory text,
(b)(5)(i), and (b)(10);
■
■
E:\FR\FM\16DER1.SGM
16DER1
68340
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Rules and Regulations
c. Removing the comma at the end of
paragraph (b)(5)(i) and adding a
semicolon in its place;
■ d. Revising paragraphs (c) and (e)
introductory text;
■ e. Removing the commas at the ends
of paragraphs (e)(1) and (2) and adding
semicolons in their place; and
■ f. Revising paragraphs (f) and (h)(1)
and (2).
The revisions read as follows:
■
§ 814.20
Application.
lotter on DSKBCFDHB2PROD with RULES
*
*
*
*
*
(b) Unless the applicant justifies an
omission in accordance with paragraph
(d) of this section, a PMA shall include
in electronic format:
*
*
*
*
*
(2) A table of contents that specifies
the volume and page number for each
item referred to in the table. A PMA
shall include separate sections on
nonclinical laboratory studies and on
clinical investigations involving human
subjects. A PMA shall be submitted as
a single version. The applicant shall
include information that it believes to
be trade secret or confidential
commercial or financial information in
the PMA and identify the information
that it believes to be trade secret or
confidential commercial or financial
information.
*
*
*
*
*
(c) Pertinent information in FDA files
specifically referred to by an applicant
may be incorporated into a PMA by
reference. Information in a master file or
other information submitted to FDA by
a person other than the applicant will
not be considered part of a PMA unless
such reference is authorized in a record
submitted to FDA by the person who
submitted the information or the master
file. If a master file is not referenced
within 5 years after the date that it is
submitted to FDA, FDA will return the
master file to the person who submitted
it.
*
*
*
*
*
(e) The applicant shall periodically
update its pending application with
new safety and effectiveness
information learned about the device
from ongoing or completed studies that
may reasonably affect an evaluation of
the safety or effectiveness of the device
or that may reasonably affect the
statement of contraindications,
warnings, precautions, and adverse
reactions in the draft labeling. The
update report shall be consistent with
the data reporting provisions of the
protocol. The applicant shall submit any
update report in electronic format and
shall include in the report the number
assigned by FDA to the PMA. These
VerDate Sep<11>2014
16:34 Dec 13, 2019
Jkt 250001
updates are considered to be
amendments to the PMA. The time
frame for review of a PMA will not be
extended due to the submission of an
update report unless the update is a
major amendment under § 814.37(c)(1).
The applicant shall submit these
reports—
*
*
*
*
*
(f) If a color additive subject to section
721 of the Federal Food, Drug, and
Cosmetic Act is used in or on the device
and has not previously been listed for
such use, then, in lieu of submitting a
color additive petition under part 71 of
this chapter, at the option of the
applicant, the information required to
be submitted under part 71 may be
submitted as part of the PMA. When
submitted as part of the PMA, the
information shall be submitted in
electronic format. A PMA for a device
that contains a color additive that is
subject to section 721 of the Federal
Food, Drug, and Cosmetic Act will not
be approved until the color additive is
listed for use in or on the device.
*
*
*
*
*
(h) * * *
(1) For devices regulated by the
Center for Devices and Radiological
Health, send it to the current address
displayed on the website https://
www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the
Center for Biologics Evaluation and
Research, send it to the current address
displayed on the website https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CBER/ucm385240.htm.
*
*
*
*
*
■ 9. Amend § 814.39 by revising
paragraph (c)(1) to read as follows:
§ 814.39
§ 814.104
Original applications.
*
*
*
*
*
(d) Address for submissions and
correspondence. All original HDEs,
amendments and supplements, as well
as any correspondence relating to an
HDE, must be provided in electronic
format. These materials must be sent or
delivered to one of the following:
(1) For devices regulated by the
Center for Devices and Radiological
Health, send it to the current address
found on the website https://
www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the
Center for Biologics Evaluation and
Research, send it to the current address
displayed on the website https://
www.fda.gov/AboutFDA/CentersOffices/
OfficeofMedicalProductsandTobacco/
CBER/ucm385240.htm.
*
*
*
*
*
Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019–27047 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
PMA supplements.
*
*
*
*
*
(c)(1) All procedures and actions that
apply to an application under § 814.20
also apply to PMA supplements except
that the information required in a
supplement is limited to that needed to
support the change. A summary under
§ 814.20(b)(3) is required for only a
supplement submitted for new
indications for use of the device,
significant changes in the performance
or design specifications, circuits,
components, ingredients, principles of
operation, or physical layout of the
device, or when otherwise required by
FDA. The applicant shall submit a PMA
supplement in electronic format and
shall include information relevant to the
proposed changes in the device. A PMA
supplement shall include a separate
section that identifies each change for
which approval is being requested and
PO 00000
explains the reason for each such
change. The applicant shall submit
additional information, if requested by
FDA, in electronic format. The time
frames for review of, and FDA action on,
a PMA supplement are the same as
those provided in § 814.40 for a PMA.
*
*
*
*
*
■ 10. Amend § 814.104 by revising
paragraphs (d) introductory text and
(d)(1) and (2) to read as follows:
Frm 00016
Fmt 4700
Sfmt 4700
21 CFR Part 1301
[Docket No. DEA–511]
Technical Correction to Regulation
Regarding Registration
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule; technical correction.
AGENCY:
This final rule corrects an
erroneous cross-reference in a Drug
Enforcement Administration regulation
involving registration and ocean vessels,
aircraft, and other entities. This change
will provide clarity.
DATES: This rule is effective December
16, 2019.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
SUMMARY:
E:\FR\FM\16DER1.SGM
16DER1
]]>Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68334-68340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27047]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 807, 812, and 814
[Docket No. FDA-2018-N-0628]
RIN 0910-AH48
Medical Device Submissions: Amending Premarket Regulations That
Require Multiple Copies and Specify Paper Copies To Be Required in
Electronic Format
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
issuing a final rule amending requirements for medical device premarket
submissions to remove paper and multiple copies and replace them with
requirements for a single submission in electronic format. This action
would reduce the number of copies in electronic format required, thus
improving and making more efficient the FDA's premarket submission
program for medical devices.
DATES: This rule is effective January 15, 2020.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Diane Garcia, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G609, Silver Spring, MD 20993, 301-796-6559, email:
[email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
A. Need for the Regulation/History of This Rulemaking
B. Summary of Comments to the Proposed Rule
C. General Overview of Final Rule
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
A. Introduction
B. Description of General Comments and FDA Response
VI. Proposed Effective Date
VII. Economic Analysis of Impacts
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination with Indian Tribal Governments
XII. References
I. Executive Summary
A. Purpose of the Final Rule
FDA is issuing this final rule to amend regulations on medical
device premarket submissions to remove requirements for paper and
multiple copies and replace them with requirements for a single
submission in electronic format to improve the FDA's medical device
premarket submission program and create a more efficient submission
program. Because a medical device premarket submission in electronic
format is easily reproducible, the requirement for multiple copies,
whether in electronic format or paper form, is no longer necessary. FDA
believes it is beneficial to the public to limit any burden and expense
to
[[Page 68335]]
submitters caused by requiring additional copies.
B. Summary of the Major Provisions of the Final Rule
Under this final rule, FDA is amending its regulations on medical
device submissions to remove requirements for paper and multiple copies
and replace them with requirements for a single submission in
electronic format. This requirement for a single submission in
electronic format applies to all submission types enumerated in section
745A(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 379k-1); under this final rule, FDA is only amending those
regulations that specifically mention paper and/or multiple copies of
regulatory submissions and are not consistent with this final rule.
Therefore, this final rule will amend regulations for the following
submission types: Premarket Notification (510(k)) submissions (21 CFR
807.90); Confidentiality of Information Certifications (21 CFR 807.95);
Investigational Device Exemption (IDE) applications (21 CFR 812.20);
Premarket Approval Applications (PMAs) (21 CFR 814.20); PMA supplements
(21 CFR 814.39); and Humanitarian Device Exemption (HDE) Applications
(21 CFR 814.104). These regulations cover both Center for Devices and
Radiological Health (CDRH) and Center for Biologics Evaluation and
Research (CBER) regulated devices. Submissions in electronic format
include eCopies, submissions created and submitted on CD, DVD, or flash
drive and mailed to FDA, and eSubmissions, submission package produced
by an electronic submission template.
This final rule will also amend sections of the regulations that
identify FDA's mailing address for submissions and replace those
addresses with a website address for CDRH and CBER that provides the
current mailing addresses.
C. Legal Authority
FDA is issuing this final rule from the same authority under which
FDA initially issued these regulations: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360h-360j, 360c-360j, 360bbb-8b, 371, 372, 373, 374,
375, 379, 379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264,
271. In addition, section 745A of the FD&C Act provides FDA authority
with respect to electronic format for submissions and any appeals, and
section 701(a) of the FD&C Act (21 U.S.C. 371(a)) grants FDA general
rulemaking authority to issue regulations for the efficient enforcement
of the FD&C Act.
D. Costs and Benefits
The final rule amends device regulations describing the number of
copies firms must submit with a premarket presubmission or submission.
The final rule also amends all device regulations containing a
reference to the specific form of a submission to require a submission
in electronic format. The final rule will produce cost savings for
firms without imposing any additional regulatory burdens for
submissions or affecting the Agency's ability to review submissions.
Firms will incur minimal administrative costs to read and understand
the rule. We expect the economic impact of this regulation to be a
total net costs savings yielding positive net benefits.
We estimate that the final rule will result in annualized benefits
of $1.76 million at a 3 percent discount rate and $1.76 million at a 7
percent discount rate, over 10 years. We also estimate that the final
rule will result in annualized costs of $0.75 million at a 3 percent
discount rate and $0.87 million at a 7 percent discount rate, over 10
years.
II--Table of Abbreviations/Commonly Used Acronyms in This Document
------------------------------------------------------------------------
Term, abbreviation, or acronym What it means
------------------------------------------------------------------------
510(k)................................. Premarket Notification.
Agency................................. Food and Drug Administration.
CFR.................................... Code of Federal Regulations.
eCopy.................................. Submissions created and
submitted on CD, DVD, or flash
drive and mailed to FDA.
eSubmissions........................... Submission package produced by
an electronic submission
template.
EO..................................... Executive Order.
FD&C Act............................... Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 301 et
seq.
FDA.................................... Food and Drug Administration.
FDARA.................................. FDA Reauthorization Act of 2017
(Pub. L. 115-52).
FDASIA................................. Food and Drug Administration
Safety and Innovation Act
(Pub. L. 112-144).
HDE.................................... Humanitarian Device Exemption.
IDE.................................... Investigational Device
Exemption
PMA.................................... Premarket Approval Application.
------------------------------------------------------------------------
II. Background
A. Need for the Regulation/History of the Rulemaking
On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform
Agenda'' was issued. One of the provisions in the E.O. requires
Agencies to evaluate existing regulations and make recommendations to
the Agency head regarding their repeal, replacement, or modification,
consistent with applicable law. As part of this initiative, FDA is
updating regulations as specified in this final rule.
FDA's current medical device regulations that require multiple
copies and paper submissions predate the authority provided to FDA in
the FD&C Act to require submissions in electronic format (see 21 CFR
parts 807, 812, and 814 and section 745A of the FD&C Act).
The FD&C Act was amended by the Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144) (see section 745A(b) of
the FD&C Act and section 1136 of FDASIA). The amendments in FDASIA
provided that after FDA issued guidance on the submission of electronic
copies (eCopies), the submission of eCopies would be required for
presubmissions and submissions and any supplements to these
presubmissions and submissions for medical devices. (For sections
requiring submission, see sections 510(k), 513(f)(2)(A), 515(c), (d)
and (f), 520(g) and (m), and 564 of the FD&C Act (21 U.S.C. 360(k),
360c(f)(2)(A), 360e(c), (d) and (f), 360j(g) and (m), and 360bbb-3 or
section 351 of the Public Health Service Act (42 U.S.C. 262).) Congress
granted explicit statutory authorization to FDA to implement eCopy
requirements by providing through guidance the standards and criteria
for waivers and exemptions (section 745(b)(1) and (2) of the FD&C Act).
On January 2, 2013, FDA published the guidance entitled ``eCopy
Program for Medical Device Submissions'' (eCopy guidance). The issuance
of the eCopy guidance marked the beginning of the eCopy program. The
2013 guidance was superseded by an updated guidance of the same title
issued on December 3, 2015. The eCopy guidance recommends that one
paper copy should be submitted, and that any additional copies required
under the regulations be submitted as eCopies. While the eCopy guidance
did not change the overall number of copies required for any
submission, the guidance states that eCopies should be provided in lieu
of some of the paper copies. The guidance also outlines other
requirements for eCopies. The eCopy
[[Page 68336]]
guidance provides instructions for the processing and technical
standards for eCopies based on FDA's experience with the program (Ref.
1).
In 2017, the FD&C Act was amended by the FDA Reauthorization Act of
2017 (FDARA) (Pub. L. 115-52) (see section 745A(b)(3) of the FD&C Act
and section 207 of FDARA). The amended provisions in the FD&C Act
require presubmissions and submissions (the same types of submissions
as required eCopies), any supplements to such presubmissions or
submissions for devices, and any appeals of action taken with respect
to such presubmissions or submissions, including devices under the
Public Health Service Act, to be submitted solely in electronic format
as specified by FDA in guidance (section 745A(b)(3) of the FD&C Act).
FDA is amending current medical device regulations that require
multiple copies and paper submissions to improve the efficiency of the
review process by allowing immediate availability of an electronic
version for review, rather than relying solely on the paper version.
Because a submission in electronic format is easily reproducible, the
requirement for multiple copies (whether in electronic format or paper
form) is no longer necessary. Furthermore, FDA believes it is
beneficial to the public to limit any burdens and expenses to
submitters caused by requiring additional copies.
In the Federal Register of September 13, 2018 (83 FR 46444), FDA
issued a proposed rule entitled ``Medical Device Submissions: Amending
Premarket Regulations That Require Multiple Copies and Specify Paper
Copies To Be Allowed in Electronic Format'' and requested public
comments by December 12, 2018.
FDA believes this rule will result in meaningful burden reduction
while allowing the Agency to achieve our public health mission and
fulfill statutory obligations.
B. Summary of Comments to the Proposed Rule
In response to the proposed rule, FDA received 14 comments--from
industry organizations, individuals, and anonymous. The comments on the
proposed rule were all generally supportive of the proposed amendments
regarding submissions in electronic format. Commenters expressed that
premarket submissions in electronic format will make the process more
efficient, faster, lower the costs, and promote innovation as well as
speed up accessibility for patient care. Commenters also noted that the
submissions in electronic format will reduce paper, errors and allow
storage and easy access to submissions. One of the commenters suggested
including additional regulations for submissions in electronic format
and recommended corresponding changes to the proposed amendments.
C. General Overview of the Final Rule
FDA is issuing this final rule to amend regulations for medical
device premarket submissions to remove the requirements for multiple
copies of submissions and to instead require a single submission in
electronic format. The revised submissions include premarket
notification submissions (510(k) submissions) (Sec. 807.90);
confidentiality of information certification (Sec. 807.95);
investigational device exemption applications (Sec. 812.20); PMAs
(Sec. 814.20), including PMA supplements (Sec. 814.39); and
humanitarian device exemption applications (Sec. 814.104). This final
rule also affects submissions for CBER regulated devices.
This final rule will also amend the regulations that identify FDA's
mailing addresses for submissions by replacing those addresses with
website addresses for CDRH and CBER that provide the current mailing
addresses.
The submission of an eCopy is separate and distinct from FDA's
electronic submission programs (eSubmitter), which include the CDRH's
510(k) eSubmissions Pilot Program (79 FR 24732, May 1, 2014).
Nevertheless, FDA considers both eCopies, submissions created and
submitted on a CD, DVD, or flash drive and mailed to FDA, and
eSubmissions, submission package produced by an electronic submission
template, to be submissions in electronic format. While eCopy provides
for submissions to be in electronic format, the eCopy submissions must
still be mailed to FDA. By contrast, eSubmitter allows for electronic
submissions to be transmitted over the internet. FDA has been moving
toward transforming all regulatory submissions from mailed copies to
electronic means via the internet. Since January 1999, FDA has accepted
voluntary electronic submissions through eSubmitter. FDA presently
utilizes the Electronic Submission Gateway for the receipt and
processing of many types of electronic regulatory submissions (Ref. 2).
IV. Legal Authority
FDA is issuing this final rule from the same authority under which
FDA initially issued these regulations: 21 U.S.C. 321, 331, 351, 352,
353, 355, 360, 360h-360j, 360c-360j, 360bbb-8b, 371, 372, 373, 374,
375, 379, 379e, 381, 382, 393; 42 U.S.C. 216, 241, 262, 263b-263n, 264,
271. In addition, section 745A of the FD&C Act provides FDA authority
with respect to electronic format for submissions and any appeals, and
section 701(a) of the FD&C Act grants FDA general rulemaking authority
to issue regulations for the efficient enforcement of the FD&C Act.
V. Comments on the Proposed Rule and FDA Response
A. Introduction
In response to the proposed rule announcing FDA's intent to amend
requirements for medical device premarket submissions to remove paper
and multiple copies and replace them with requirements for a single
submission in electronic format, FDA received 14 comments--from
industry organizations, individuals, and anonymous.
We describe and respond to the comments in section V.B. We have
numbered each comment to help distinguish between different comments.
We have grouped similar comments under the same number for purposes of
our responses. The number assigned to each comment or comment topic is
purely for organizational purposes and does not signify the comment's
value or importance or the order in which comments were received.
B. Description of Comments and FDA Response
Several commenters made general remarks supporting the proposed
rule without focusing on a particular proposed provision. In the
following paragraphs, we discuss and respond to such general comments
as well as more specific comments.
(Comment 1) Several commenters were supportive of the
implementation of the proposed amendments to regulations on medical
device submissions to remove requirements for paper and multiple copies
and replace them with requirements for a single submission in
electronic format. The commenters suggested that single copy
submissions in electronic format will be easier, improve efficiency of
the review process, reduce paper, costs, errors, and support
innovation. The commenters also suggested that submissions in
electronic format will provide easy storage and access to records and
reduce the time for creating the submissions. Most of the commenters
did not suggest any further edits to the proposed rule. A commenter
suggested assigning IDs or reference numbers to each product to
[[Page 68337]]
advance post market surveillance of medical devices.
(Response 1) FDA agrees with the commenters that submission in
electronic format will improve the efficiency with lower costs and
easier storage and access to records. Regarding the comment related to
the ID/reference numbers, FDA did not modify the final rule based on
this comment as it is outside the scope of the requirement for a single
submission in electronic format. Accordingly, in response to this
comment, FDA did not make any changes in the final rule.
(Comment 2) A commenter supported the implementation of the rule
but also suggested that electronic submissions be made via the
internet, in an Extensible Markup Language (XML) format. The commenter
suggested that FDA should be developing specifications for industry
submission authoring software that would integrate directly into FDA's
review platform; the commenter explained that this type of submission
authoring software could create elements of structured data within a
submission.
(Response 2) In response, FDA acknowledges the advantages of
electronic submissions. FDA notes that the rule is written broadly
enough to permit electronic submissions and allow for structured data
when such platforms are available. Accordingly, we have made no change
in the final rule.
(Comment 3) A commenter suggested applying a logical and least
burdensome approach in all FDA guidances, regulatory decisions, and
administrative processes. The commenter further indicated that they
supported removing paper and multiple copies and replacing them with a
single submission in electronic format.
(Response 3) FDA acknowledges this comment and agrees that the
least burdensome principles should be considered in all FDA guidances,
regulatory decisions and administrative processes (Ref. 3). FDA
believes this final rule limits any burdens and expenses to submitters
caused by requiring multiple copies of a submission. Accordingly, in
response to this comment, FDA did not make any changes in the final
rule.
(Comment 4) A commenter acknowledged the benefits of the rule and
supported implementation with a recommendation to amend the rule and
include additional regulations within the scope and description of the
rule. Specifically, the commenter proposed revising FDA's regulation
for devices to remove the requirement for multiple copies of
submissions and to instead require one electronic version for those
regulations noted in the proposed rule in addition to the following:
Content and format of a 510(k) summary (Sec. 807.92); content and
format of a 510(k) statement (Sec. 807.93); format of a class III
certification (Sec. 807.94); supplemental applications (Sec. 812.35);
reports (Sec. 812.150); reports (Sec. 814.84); PMA amendments and
submitted PMAs (Sec. 814.37); and post approval requirements and
reports (Sec. 814.126).
(Response 4) FDA agrees with the commenter that this rule should
apply to all premarket regulatory submissions that are specified in
section 745A(b) of the FD&C Act. The requirement for a single
submission in electronic format applies to all submission types that
fall within the provisions listed in section 745A(b) of the FD&C Act;
under this final rule, FDA is only amending those regulations that
specifically mention paper and/or multiple copies of such regulatory
submissions and are not consistent with this final rule. Any
regulations that are currently silent on the method for submitting such
regulatory submissions to the FDA will not be modified as they remain
consistent with the final rule. Accordingly, in response to this
comment, FDA did not make any changes in the final rule.
VI. Effective Date
The final rule will become effective 30 days after the date of
publication in the Federal Register.
VII. Economic Analysis of Impacts
We have examined the impacts of the final rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O.s 12866 and 13563 direct us to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
final rule is not a significant regulatory action as defined by E.O.
12866.
The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the final rule amends the existing premarket
regulations requiring multiple copies and paper submissions to instead
require submissions in electronic format without imposing any new
requirements, we certify that the final rule will not have a
significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This final rule will not
result in an expenditure in any year that meets or exceeds this amount.
This final rule will amend the device regulations describing the
number of copies firms must submit with a premarket presubmission or
submission. The final rule will also amend all device regulations
containing a reference to the specific form of a submission media
(i.e., paper copies) to require a submission in electronic format. The
final rule will produce cost-savings for firms without imposing any
additional regulatory burdens for submissions or affecting the Agency's
ability to review submissions. Firms will incur minimal administrative
costs to read and understand the rule. We expect the economic impact of
this regulation to be a total net costs savings yielding positive net
benefits.
We have developed a comprehensive final Economic Analysis of
Impacts that assesses the impacts of the final rule. The full analysis
of economic impacts is available in the docket for this final rule
(Ref. 4) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
Summary of Costs and Benefits
Table 1 summarizes the benefits, costs, and distributional effects
of the final rule. We estimate that the final rule will result in
annualized net benefits of $1.76 million with a 3 percent discount rate
and $1.76 million with a 7 percent discount rate, over 10 years. We
also estimate that the final rule will result in annualized costs of
$0.75 million at a 3 percent discount rate and $0.87 million at a 7
percent discount rate, over 10 years.
[[Page 68338]]
Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Units
------------------------------------
Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/ $1.76 $0.63 $3.73 2017 7 10 Benefits are cost savings.
year. 1.76 0.63 3.73 2017 3 10 Benefits are cost savings.
Annualized Quantified............. .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
------------------------------------------------------------------------
Qualitative.......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized $millions/ 0.87 0.87 0.87 2017 7 10
year. 0.75 0.75 0.75 2017 3 10
Annualized Quantified............. .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
------------------------------------------------------------------------
Qualitative.......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized .......... .......... .......... .......... 7 ..........
$millions/year. .......... .......... .......... .......... 3 ..........
------------------------------------------------------------------------
From:
To:
-----------------------------------------------------------------------------------------------------------------
Other Annualized Monetized .......... .......... .......... .......... 7 ..........
$millions/year. .......... .......... .......... .......... 3 ..........
------------------------------------------------------------------------
From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
In line with E.O. 13771, in Table 2 we present annualized values of
costs and cost savings over an infinite time horizon. With a 7 percent
discount rate, the estimated annualized net cost-savings equal $1.31
million in 2016 dollars over an infinite horizon. Based on these cost
savings, this final rule, is considered a deregulatory action under
E.O. 13771.
Table 2--Summary of the Executive Order 13771 Impacts of the Final Rule
Over an Infinite Time Horizon
[2016 $ millions]
------------------------------------------------------------------------
Primary Primary
estimate (7%) estimate (3%)
------------------------------------------------------------------------
Present Value of Costs.................. $6.43 $6.43
Present Value of Cost Savings........... 26.45 59.40
Present Value of Net Costs.............. (20.01) (52.97)
Annualized Costs........................ 0.42 0.19
Annualized Cost Savings................. 1.73 1.73
Annualized Net Costs.................... (1.31) (1.54)
------------------------------------------------------------------------
Note: Values in parentheses denote net negative costs (i.e., cost-
savings).
VIII. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(h) and 25.34(a) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IX. Paperwork Reduction Act of 1995
FDA concludes that this final rule contains no collection of
information subject to review by the Office of Management and Budget
under the Paperwork Reduction Act of 1995. Rather, the final rule
removes requirements to submit multiple paper copies of certain medical
device presubmissions and submissions and replaces them with one copy
in an electronic format.
X. Federalism
We have analyzed this final rule in accordance with the principles
set forth in E.O. 13132. FDA has determined that the rule does not
contain policies that have substantial direct effects on the States, on
the relationship between the National Government and the States, or on
the distribution of power and responsibilities among the various levels
of government. Accordingly, we conclude that the rule does not contain
policies that have federalism implications as defined in the E.O. and,
consequently, a federalism summary impact statement is not required.
XI. Consultation and Coordination With Indian Tribal Governments
We have analyzed this final rule in accordance with the principles
set forth in E.O. 13175. We have determined that the rule does not
contain policies that would have a substantial direct effect on one or
more Indian Tribes, on the relationship between the Federal Government
and Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the
[[Page 68339]]
Executive Order and, consequently, a tribal summary impact statement is
not required.
XII. References
The following references are on display at Dockets Management Staff
(see ADDRESSES) and are available for viewing by interested persons
between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
1. ``eCopy Program for Medical Device Submissions; Guidance for
Industry and Food and Drug Administration Staff'' available at:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/ecopy-program-medical-device-submissions.
2. Electronic Submission Gateway procedure for electronic
regulatory submission is available at: https://www.fda.gov/industry/electronic-submissions-gateway/about-esg.
3. ``The Least Burdensome Provisions: Concept and Principles;
Guidance for Industry and Food and Drug Administration Staff''
available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
4. Economic impacts analysis for this final rule available at:
https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/medical-device-submissions-amending-premarket-regulations-require-multiple-copies-and-specify-paper.
List of Subjects
21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
21 CFR Part 812
Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.
21 CFR Part 814
Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 807, 812, and 814 are amended as follows:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
0
1. The authority citation for part 807 is revised to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 360bbb-8b, 371, 374, 379k-1, 381, 393; 42 U.S.C. 264, 271.
0
2. Amend Sec. 807.90 by revising paragraph (a), removing and reserving
paragraph (b), and revising paragraph (c) to read as follows:
Sec. 807.90 Format of a premarket notification submission.
* * * * *
(a)(1) For devices regulated by the Center for Devices and
Radiological Health, be addressed to the current address displayed on
the website https://www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, be addressed to the current address displayed on the
website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm; or for devices
regulated by the Center for Drug Evaluation and Research, be addressed
to the Central Document Room, Center for Drug Evaluation and Research,
Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD
20705-1266. Information about devices regulated by the Center for
Biologics Evaluation and Research is available at https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/default.htm.
(3) All inquiries regarding a premarket notification submission
should be sent to the address in this section or one of the current
addresses displayed on the Food and Drug Administration's website.
* * * * *
(c) Be submitted as a single version in electronic format.
* * * * *
0
3. Amend Sec. 807.95 by revising paragraph (b)(1) introductory text to
read as follows:
Sec. 807.95 Confidentiality of information.
* * * * *
(b) * * *
(1) The person submitting the premarket notification submission
requests in the submission that the Food and Drug Administration hold
as confidential commercial information the intent to market the device
and submits a certification to the Commissioner:
* * * * *
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS
0
4. The authority citation for part 812 is revised to read as follows:
Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360bbb-8b, 371, 372, 374, 379e, 379k-1, 381, 382, 383; 42
U.S.C. 216, 241, 262, 263b-263n.
0
5. Amend Sec. 812.19 by revising paragraphs (a)(1) and (2) to read as
follows:
Sec. 812.19 Addresses for IDE correspondence.
(a) * * *
(1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address displayed on the
website https://www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
0
6. Amend Sec. 812.20 by revising paragraph (a)(3) to read as follows:
Sec. 812.20 Application.
(a) * * *
(3) A sponsor shall submit a signed ``Application for an
Investigational Device Exemption'' (IDE application), together with
accompanying materials in electronic format, to one of the addresses in
Sec. 812.19, and if eCopy by registered mail or by hand. Subsequent
correspondence concerning an application or a supplemental application
shall be submitted in electronic format and if eCopy by registered mail
or by hand.
* * * * *
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
0
7. The authority citation for part 814 is revised to read as follows:
Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 379k-1, 381.
0
8. Amend Sec. 814.20 by:
0
a. Revising paragraph (b) introductory text and paragraph (b)(2);
0
b. Removing the phrase ``of the act'' and adding in its place ``of the
Federal Food, Drug, and Cosmetic Act'' in paragraphs (b)(5)
introductory text, (b)(5)(i), and (b)(10);
[[Page 68340]]
0
c. Removing the comma at the end of paragraph (b)(5)(i) and adding a
semicolon in its place;
0
d. Revising paragraphs (c) and (e) introductory text;
0
e. Removing the commas at the ends of paragraphs (e)(1) and (2) and
adding semicolons in their place; and
0
f. Revising paragraphs (f) and (h)(1) and (2).
The revisions read as follows:
Sec. 814.20 Application.
* * * * *
(b) Unless the applicant justifies an omission in accordance with
paragraph (d) of this section, a PMA shall include in electronic
format:
* * * * *
(2) A table of contents that specifies the volume and page number
for each item referred to in the table. A PMA shall include separate
sections on nonclinical laboratory studies and on clinical
investigations involving human subjects. A PMA shall be submitted as a
single version. The applicant shall include information that it
believes to be trade secret or confidential commercial or financial
information in the PMA and identify the information that it believes to
be trade secret or confidential commercial or financial information.
* * * * *
(c) Pertinent information in FDA files specifically referred to by
an applicant may be incorporated into a PMA by reference. Information
in a master file or other information submitted to FDA by a person
other than the applicant will not be considered part of a PMA unless
such reference is authorized in a record submitted to FDA by the person
who submitted the information or the master file. If a master file is
not referenced within 5 years after the date that it is submitted to
FDA, FDA will return the master file to the person who submitted it.
* * * * *
(e) The applicant shall periodically update its pending application
with new safety and effectiveness information learned about the device
from ongoing or completed studies that may reasonably affect an
evaluation of the safety or effectiveness of the device or that may
reasonably affect the statement of contraindications, warnings,
precautions, and adverse reactions in the draft labeling. The update
report shall be consistent with the data reporting provisions of the
protocol. The applicant shall submit any update report in electronic
format and shall include in the report the number assigned by FDA to
the PMA. These updates are considered to be amendments to the PMA. The
time frame for review of a PMA will not be extended due to the
submission of an update report unless the update is a major amendment
under Sec. 814.37(c)(1). The applicant shall submit these reports--
* * * * *
(f) If a color additive subject to section 721 of the Federal Food,
Drug, and Cosmetic Act is used in or on the device and has not
previously been listed for such use, then, in lieu of submitting a
color additive petition under part 71 of this chapter, at the option of
the applicant, the information required to be submitted under part 71
may be submitted as part of the PMA. When submitted as part of the PMA,
the information shall be submitted in electronic format. A PMA for a
device that contains a color additive that is subject to section 721 of
the Federal Food, Drug, and Cosmetic Act will not be approved until the
color additive is listed for use in or on the device.
* * * * *
(h) * * *
(1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address displayed on the
website https://www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
0
9. Amend Sec. 814.39 by revising paragraph (c)(1) to read as follows:
Sec. 814.39 PMA supplements.
* * * * *
(c)(1) All procedures and actions that apply to an application
under Sec. 814.20 also apply to PMA supplements except that the
information required in a supplement is limited to that needed to
support the change. A summary under Sec. 814.20(b)(3) is required for
only a supplement submitted for new indications for use of the device,
significant changes in the performance or design specifications,
circuits, components, ingredients, principles of operation, or physical
layout of the device, or when otherwise required by FDA. The applicant
shall submit a PMA supplement in electronic format and shall include
information relevant to the proposed changes in the device. A PMA
supplement shall include a separate section that identifies each change
for which approval is being requested and explains the reason for each
such change. The applicant shall submit additional information, if
requested by FDA, in electronic format. The time frames for review of,
and FDA action on, a PMA supplement are the same as those provided in
Sec. 814.40 for a PMA.
* * * * *
0
10. Amend Sec. 814.104 by revising paragraphs (d) introductory text
and (d)(1) and (2) to read as follows:
Sec. 814.104 Original applications.
* * * * *
(d) Address for submissions and correspondence. All original HDEs,
amendments and supplements, as well as any correspondence relating to
an HDE, must be provided in electronic format. These materials must be
sent or delivered to one of the following:
(1) For devices regulated by the Center for Devices and
Radiological Health, send it to the current address found on the
website https://www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation
and Research, send it to the current address displayed on the website
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
* * * * *
Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27047 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P
